NCT00285766

Brief Summary

Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2002

Typical duration for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

January 31, 2006

Last Update Submit

April 21, 2008

Conditions

Major Depression

Keywords

Depression

Interventions

Selegiline Transdermal SystemDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
* Men/Women in good health 65 years or older * Ability to read, understand and sign study informed consent * Major depression- mild to severe based on rating scale

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

Mohammed Bari, M.D.

Chula Vista, California, 91910, United States

Location

Charles Meredith, M.D.

San Diego, California, 92108, United States

Location

Daniel Zimbroff, M.D.

Upland, California, 94589, United States

Location

Kathleen Toups, M.D.

Walnut Creek, California, 94589, United States

Location

Abbey Strauss, M.D.

Boynton Beach, Florida, 33437, United States

Location

Barry Baumel, M.D.

Miami Beach, Florida, 33154, United States

Location

Margarita Nunez, M.D.

St. Petersburg, Florida, 33702, United States

Location

Mildred Farmer, M.D.

St. Petersburg, Florida, 33710, United States

Location

Larry Eisner, M.D.

Tamarack, Florida, 33321, United States

Location

Andrew Cutler, M.D.

Winter Park, Florida, 32789, United States

Location

Robert Riesenberg, M.D.

Atlanta, Georgia, 30308, United States

Location

James Hartford, M.D.

Florence, Kentucky, 41042, United States

Location

Mitchel Kling, M.D.

Baltimore, Maryland, 21201, United States

Location

Louise Beckett, M.D.

Oklahoma City, Oklahoma, 73103, United States

Location

Penny Barnhart, M.D.

Wichita Falls, Texas, 76309, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

August 1, 2002

Study Completion

July 1, 2005

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(15)